Ukuqonda Ama - Stakes Esikhali Sezokwelapha Esiseshini Esihlobisayo

Umshini wezokwelapha oshintshayo umelela olunye uhlobo oluyingozi kakhulu lokuphazamisa komkhiqizo ngoba izisulu zivame ukuba yiziguli ezisengozini ezithembele ezintweni ezinjengezimpompo ze-insulin, izishaya-ndlela, izikhiphi, izikhuthazo, iziphekezeli, izikhuthazo zokufaka umoya, nezimiso zemithi ukuze ziqhubeke. Ushintsho olulodwa lwenhloso lungaholela ekusebenziseni ngokweqile, ukushayeka kogesi, ukungenwa yizifo, ukuhluleka komshini, noma ukufa. Uma izinhlangano ezilawula umthetho zicabanga ukuthi ziyaphazamisa, kumelwe zihambe ngokushesha ukuze ziqoqe ubufakazi futhi ziyeke ukulimala okwengeziwe. Kodwa i-Gandementation Eyesine ihlala ihlola amandla kahulumeni, ifuna ukuba ukuphenya nokuquleka okunengqondo futhi kusekelwe ngokusemthethweni ngesizathu esinikezwa yisizathu. Ukuvikela impilo yomphakathi ngesivikelo somthetho wemithetho yezomthetho kudinga ukuqonda okuphelele ukugcinwa lapho imishini isebenza ngokusemthethweni.

Umthetho uyinkimbinkimbi kakhulu ngoba amacebo ezokwelapha afakwa kabanzi emfuthweni nasemithethweni kahulumeni. Ukudayisa kungaphazamisa iMidlalo kahulumeni , iDismu, neCosmetic Act (FD&C Act ], evimbela ukungcoliswa noma ukudukiswa kwemishini, kanye nemithetho yobugebengu enjenge-18 U.S.C. 765 (isebenzisa imikhiqizo yabathengi) kanye ne-18.C. . . . . . . . . 131 (ukukhohlisa, uma ukuphamba okungakuyingxenye yemigomo). Ngokuvamile iqoqo lemithetho yomthetho yomthetho yomthetho esemthethweni. Ukuba ukucwaninga indawo lapho ilungiswe ngamaqhinga, lapho isibhedlela esisebenza ngendlela elungiswe ngamabomu, noma ithuluzi lomuntu ngamunye, i-uthoni, i-eod project, i-od produced, i-od productive, i-od productived prorivement, i-projectsment,

Ukusebenza Ngokomthetho Ngezimfuneko Ezinhle

ISichibiyelo sesine se-United States Constitution simemezela ukuthi “ilungelo labantu lokuvikelwa kubantu babo, izindlu, amaphepha, nemiphumela, ngokuphenywa okungenangqondo nokuquleka, ngeke liphulwe, futhi akukho maWarrant azakuvela, kodwa ngokunokwenzeka, esekelwa u-Oath noma imvume, futhi ikakhulukazi echaza indawo okumelwe ihlolwe, futhi abantu noma izinto ezizothathwa.” Lelilungiselelo limisa umthetho ongahleliwe: ukuphenya ngenqubo yokwahlulela akunangqondo uma nje bengaphazanyiswa izindaba eziqanjiwe. Lokhu kuchaza ukuthi kumelwe kube ubufakazi obungathathiwe hlangothini nomthetho futhi kuthole isiqinisekiso ngaphambi kokuba ungene ehhovisi, noma ukuhlolwa amathuluzi okushintshayo, asetshenziswa ekushintsheni, amarekhodi, noma ukuxhumana.

Imbangela efanelekile yisisekelo semfuneko yokugunyazwa. Ukuze kuqalwe isisekelo sesidingo. Abacwaningi kumelwe babonise amathuba amahle okuthi ubugebengu bungancitshiswa endaweni ethile. Ekuhlinzeni, lokhu kudinga ukubonisa ukuthi ubugebengu buye yenzeka ngamabomu noma bushiywe ngaphandle kwemvume. Ubufakazi obuhlobene nokuthi ubugebengu busendaweni ethile. Izinkantolo zihlola ngokunokwenzeka imbangela esekelwe engqikithini yezimo, zicabangela amaqiniso nezimpawu ezinengqondo ezivela emithonjeni enjengamathelini ofakazi bokuzibonela, i-opentala, iziteshi, izintathezi, uchwepheshe wemishosho, iziphakamiso, iziphakamiso, iziphakamiso zempelo, noma ukuvuma. I-ffidatvit esekela isiqinisekiso esinembaxazulu sokuzi kahle ukuze kuhlolwe i-gconstle; izintengo ezithene ngokungenayo; izithensi ze-occlogi.

Imbangela Ephawulekayo Ekwelapheni Kwemishini Ethwala Amagciwane

Ukusungula isizathu okungenzeka sokushintsha ngokuvamile kudinga ulwazi olukhethekile ngendlela amathuluzi ezokwelapha asebenza ngayo nendlela angashintshwa ngayo. Ngokwesibonelo, uma umshini wedialysis ungasebenzi kahle futhi isiguli sifa, abacwaningi bangadinga uchwepheshe wokuchaza ukuthi i-software yomshini ibhalwe phansi ngamabomu noma imoner yayo elimazayo. I-affidavit kufanele ichaze umshini, isimo sokuwuguqula, noma yimuphi umlando wezehlakalo ezifanayo, nokuthi ihlangana kanjani nokusolwa noma indawo. Ezimweni lapho ukuphazamiseka kucatshangelwa khona endaweni yokukhiqiza, ngokunokwenzeka izimbangela zakhiwe ngokulawula imibiko ebonisa ukulungiswa okungahambi kahle komkhiqizo ovamile, noma phakathi kwemibiko yokuthi izisebenzi zikhipha ngokusemthethweni imithetho evimbela ukuphepha.

Imfuneko ye-nexus ibaluleke kakhulu ekuhloleni ama-computer, ama-cell, noma ama-akhawunti amafu. Imishini yezokwelapha incike kakhulu kwi-software ne-metain control system, okusho ukuguqula kungahlanganisa ushintsho lwe-mitayela. Ukuphenya i-computer esolekayo ukuze kutholakale ubufakazi bokuguqula, abaphengululi kumelwe babonise ukuthi umshini ungaba nobufakazi obunjalo, ngokwesibonelo, ngoba okusolekayo kwakunendlela yokungena ku-socialdiom futhi kuthunyelwe ukwaziswa okusolekayo ku-se-servery. Izinkantolo ziye zathi isiqinisekiso sokufuna ubufakazi obuvamile, okusho ukuthi i-ffidat isho ukuthi izinhlobonhlobo zobufakazi obufunwa (p., ukuguqula i-software, ukuxhumana, ukuguqula i-proctal, ukuguqula ulwazi nge-ding, ukuguqula i-diagcomptic.).

Ukuthola Isikhulumi: Impi Yempi Nokubukeza Kokwahlulela

Ukuqinisekisa imvume kuqala ngomseshi ofuyile u-affidavit ofaka amaqiniso afaka imbangela okungenzeka. I-affidavit kumele isayinwe ngaphansi kwesifungo futhi inikezwe imantshi kahulumeni noma umahluleli wezwe. Umahluleli uhlola i-affidavit ukuze athole ukugcwala okungokomthetho futhi anqume ukuthi ikhona yini imbangela. Uma umahluleli efaka isiqinisekiso, ugunyaza umthetho ukuba uhlole indawo ekhona futhi uthathe izinto ezicaciwe. Esithweni sezokwelapha esidambisa izindaba, isiqinisekiso kufanele sithathwe ngokucacile, noma izakhi ezihlobene, noma imibiko ehlobene, namathuluzi noma iziphi izinto ezisetshenziswa ekuhlinzeni ubugebengu.

Ngenxa yokuthi amathuluzi ezokwelapha alawulwa kakhulu, izimvume ezihlasela isikhungo sokwakha kumelwe zivumelane nanoma yiziphi izithiyo ezilawulayo. Ngokwesibonelo, i-FDA&C Act inikeza abacwaningi be-FDA igunya lokuhlola i-inspect[ amarekhodi athile nezindawo ezingenamvume ngaphansi kwezimo ezilinganiselwe (izici ezibekwe ngezansi), kodwa izivumelwano zokuhlola ubugebengu zisetshenziswa kakhulu lapho ukuguqula ngenhloso futhi ubufakazi bungafihlwa. Ukuhlolwa phakathi kwezikhulu ze-FDA nabashushisi kuvamile kuqinisekisa ukuthi isicelo sokwaziswa sihlanganisa imininingwane eyanele yobuchwepheshe ukuze simelane nezinyathelo zokuhlikiselwa kamuva.

Uma imvume ikhishwa ngokungafanele, ngokwesibonelo, uma izikhulu zeqisa ububanzi bokufuna noma zehluleka ukungqongqoza nokumemezela ukuba khona kwazo (/noma ibuphi ubufakazi obutholakalayo bungacinywa ngaphansi komthetho wokususa. Ezimweni zokushintsha lapho ukucindezelwa kungalimaza ikhono lomshushisi lokuqinisekisa noma ukuqapha, ukunaka kokunakekela ngokucophelela ukunikeza izimfuneko kubalulekile. Izinkantolo ziye zafihla ubufakazi ezicatshangelweni zomkhiqizo lapho i-affidavits ithembele elwazini oluyimfihlo, ukuntuleka, noma ihluleka ukusungula ukuxhumana phakathi kwe-osolithi nendawo ephenywayo.

Abahlukile Endinganisweni Eqaphile

Nakuba indinganiso yemvume iqinile, izimpawu eziningana ezimiswe kahle zivumela ukusesha okungagunyazi ukuphenya nokuquleka kwemishini yezokwelapha ephazamisayo. Lokhu kukhetha kulula ukukuthatha futhi kumelwe kuthethelelwe ngezizathu eziphuthumayo noma ezinye izimo eziphoqelelayo. Okuvame ukukhethwa yizimo eziguquguqukayo, imvume, umbono ocacile, nokuphenyiswa kwezezobuqondisi ezimbonini ezilawulwa kakhulu.

Izimo Ezibi

Izimo eziguquguqukayo zivumela izikhulu ukuba zithathe uphengululo olungenasiqinisekiso uma kunosongo olusheshayo ekuphileni, ingozi yokulahlekelwa ubufakazi, noma amathuba okuthi usolwa uzobaleka ngaphambi kokuba kutholakale imvume. Emishinini yezokwelapha eshintsha amacala, ngokuvamile kuvela ngenxa yokuthi imishini eshintshiwe iyaqhubeka isetshenziswa ezigulini. Izibalo zingabuqeda ubufakazi obuthola izinhlu zemishini empompayo engase ingcoliswe ngamabomu, zingase zidinge ukungena egumbini lesibhedlela ukuze zikhiphe impompi futhi zivimbele izingozi zeziguli. Ngokufanayo, uma usoleka uyaqhubeka nokusetshenziswa kwemishini yokulungisa futhi uqede ubufakazi ngenkathi yokufaka izingobo zomthetho noma ukususa izinombolo, izikhulu zingangena ngaphandle kwemfundiso egciniwe.

Izinkantolo zifuna ukuba uhulumeni abonise isisekelo esiqotho sokukholelwa ukuthi ukuxosha kwakukhona ngesikhathi sokufuna. Ukukhathazeka ngokulimala akwanele; kumelwe kube namaqiniso aqondile abonisa ukuthi ukulinda imvume ethile kungabangela ukulimala noma ukulahlekelwa ubufakazi. Ngokwesibonelo, uma imibiko yokufusha i-mouse ephonsa impondo iveza ukuthi isisebenzi esidabukile siphazamisa abakhiqizi bejubane emgqeni wokukhiqiza futhi indawo ivaliwe, izikhulu zingaphetha ngokunengqondo ukuthi ukungena okungena okungena ngokungena ngokufanelekile kuyafaneleka ukuyeka ukuphazamisa. Ngemva kokufuna, uhulumeni uphethe umthwalo wokuqinisekisa ukuthi ukukhishwa kwemoto kuyiqiniso futhi akusona nje isibopho sokuvala isibopho.

Usizo

Uma umnikazi noma umuntu ogunyaziwe evuma ngokuzithandela, izikhulu zingase zifune ngaphandle kwemvume. Uma zishintsha uphenyo, imvume ngezinye izikhathi itholakala kubaphathi bezindawo noma kubaphathi bemishini abangasoleki. Nokho, umuntu ovumayo kumelwe abe negunya elingokoqobo noma elisobala endaweni ukuze ahlolwe. Umphathi wesibhedlela angavuma ukuseshwa kwendawo yokugcina yonke, kodwa hhayi ehhovisi elivaliwe elisetshenziswa udokotela othile ophethe i-accoricktive. Ukuvala kungaxoshwa nganoma yisiphi isikhathi, futhi izikhulu zezokungagunyaza ukujezisa noma ukukhohlisa. Kuzoqungamela izikhangiso eziphakeme, ukuthola imvume ebhalwe kummeleli wenkampani ephethe inkampani yezomthetho kungcono ukugwema ukuphikisana kamuva.

Isibonisi-sithombe esiyikhohlo

Uma isikhulu sikhona ngokomthetho endaweni (njenge-pulsunt mvume, imvume, noma i-header) futhi siphawula into ebekwa indiva ngokushesha, leyonto ingase ithathwe ngaphandle kwesiqinisekiso ngaphansi kwemfundiso esobala. Ngokwesibonelo, lapho sihlola indawo ephansi esemthethweni egunyaza ukuphambanisa impompi, umphathi wekhomputha eshaye i-software eshintshiwe yohlobo olufanayo lwempompi. Isikhulu singathatha ikhomphyutha noma ithwebule i-screen ngenxa yokuthi isimo esisobala se-defaudio sisobala ngokushesha. Nokho, isikhulu kumelwe sivume ngokomthetho ukuba singene endaweni futhi sithole ubufakazi ngokungazi ukuthi i-software ehleliwe nge-rumpmming.

Ukuhlola Okulawulayo Ezindaweni Zokuthutha Imfucumfucu Ezilawulwa Ngokuqhubekayo

Abenzi bemishini yezokwelapha basebenza embonini elawulwa kakhulu. Ngaphansi komthetho we FD&C, abaphenyi be FDA bangangena futhi bahlole noma iyiphi ifektri, indawo yokugcina impahla, noma indawo lapho imishini ikhiqizwa khona, ihlelwe ngokwemingcele ethile. Lokuhlola okungalawuleki [[[FLT:]] akudingi isiqinisekiso uma iqhutshwa njengengxenye yenqubo yokuhlola okusemthethweni. INkantolo Ephakeme iye yaqaphela isikhathi eside ukuthi amabhizinisi ezimbonini ezilawulwa kakhulu anciphe kakhulu anciphile kamfihlo, futhi imvume yokuhlola okungaguquguquki kuyingxenye yomthetho womthetho. [[FLT:] E-Colunteade] i-Compling. v.[FT] [1970] futhi i-B][4] I-BExternetualgions] i-odvidenting) futhi i-octive i-octivessssssss (useke imboni engokomthetho engokomthetho oqinile womthetho omisiwe, futhi ebumbe, egunyaziwe kahulumeni, futhi

Kubenzi bemishini yezokwelapha, isikhulu se-FDA sokuhlola ngaphansi kwama-21 e-U.S.C. . . . . . 374 sinikeza abahloli ilungelo lokungena ezimbonini phakathi namahora ebhizinisi avamile, imishini yokuhlola, iqediwe futhi ingagqitywanga izinto, izitsha zokuphatha, nokuthatha amasampula. Uma umhloli enikeza izimpawu ezifanele nesaziso sokuhlola. Ngokungafani nokuhlola ubugebengu, ukuhlola, ukuhlola akudingi ukubekwa ngokomthetho kwesizathu sokuphula umthetho. Injongo iwukuqinisekisa ukuthi inqubo yamanje ekhona (CGMP) idinga ukuvumelana nemfuneko yokukhiqiza okuhle (CFRR Part 820) ngaphansi kwe-8. Nokho, uma ukuhlola okuvamile kuhlola ukucwaninga kobugebengu okuwumgomo okwenziweyo, inciphe kakhulu, kodwa izikhali ezingakho, uma kungadingi imvume. [FLD:] V.[5][5], [FT][FT],[19][19], i-FM.[196], imvume yemiststst, imvume yemistststrulense

Ukunakekelwa Okukhethekile Kwezisetshenziswa Zobuchwepheshe Nesoftware Esekelwe Kuwo

Amathuluzi ezokwelapha anamuhla axhumene kakhulu, aqukethe ama-microprocessors, i-software, namakhono okuxhumana ngocingo. Ukuthumela kungahlanganisa ukufaka ikhodi elilimazayo, ukushintsha izinqubo zemishini ngenethiwekhi, noma ukuphazamisa ukudluliswa kwemininingwane. La mazinga ahlukene aphakamisa imibuzo ekhethekile yeSijikelezo sesine sonyaka ngokuphathelene nokuhlola inqubo yemishini ye electronic comstery. Ukujikela kwe-'i-lity v. [[FLTLT][FLT] [20] [20] [20] [20, iNkanto ephakeme yeNkanto ephethe ukuthi amaphoyisa kumelwe athole isiqinisekiso socingo esithathwe emshinini ukuze abanjwe, ngenxa ye-Activesting Activess (I-ASCP]) efuna i-ARCM, noma izilungiselelo ezingokomthetho ze-octives (ngezomthetho ze-option) ezingokomthetho ze-Octive, noma ezingokomthetho ezingokomthetho ze-SCPN

Indaba ehlobene nalokhu ukuthi ukungenela i-software ye-albitar ngaphandle kokuvula ngokoqobo i-Draexption isho ukuphenywa kweSichibiyelo sesine. Izinkantolo azikawuphenduli ngokunembile lo mbuzo, kodwa izimiso ezivamile zisikisela ukuthi ukufinyelela ukwaziswa okugcinwe noma okudluliselwe ngomshini olindele ukuba uqhubeke uyimfihlo kuyi-projekthi yokufuna imvume. Isibonelo, ukuvimbela ngokungena komdlali phakathi kwe-cardiover-debrillator kanye nohlelo kungaba yi-melwane ne-Prefeapta Act. I-sciomperator kumele ithintane abashushishishisi futhi ithole isiqinisekiso esikhethekile sokuthola ukwaziswa okuvelayo esisetshenziswayo, kuhlanganise namathuluzi odayisadayo.

Izicelo Zomemezelo Owenziwe Ngemishini Yezokwelapha Nabapha Usizo Lwezempilo

Abenzi bemishini yezokwelapha banesibopho esingokomthetho nesezimiso sokuklama amathuluzi amelana nokuphambana nokubambisana nophendlo lapho kucatshangwa ukuthi ayafakelwa. I-CFDA’s Cybersecurity Literance (Ukuguqula 524B ye-FD&C Act) ikhuthaza abakhi baleyo mishini ukuba basebenzise indlela esekelwe eyingozi yokufuna ukugcinwa kwe-inthaneti, kuhlanganise nezinyathelo zokuhlola nokuguqula. Imishini kufanele isebenzise izici ezinjengezinsika ezithi zi-projective distruct, ukuhlola ukuthembeka kwe-software, kanye nokuhlola izinto ezibhalwe phansi okungagunyaziwe. Esenzekeni sophenyo, abakhi bobukhankani kumelwe baqonde ukuthi abakhi be-mkeli abangase bamelane imvume engokomthetho noma ukuhlola okungokomthetho. Obrashasha umbiko ungaholela ezimangalweni ezengeziwe ngaphansi kwe-18.C.

Abakhapheli bezokunakekelwa kwezempilo abasebenzisa amathuluzi ezokwelapha kufanele futhi babe nezimiso ezicacile zokubika ukuthi kucatshangwa ukuthi kuphazanyiswa umthetho futhi kubekwe umthetho. Ngaphansi kwe-Defic Medical Act (SMDA), izenzakalo ezithile ezimbi ezihilela amathuluzi ezokwelapha kumelwe zibikwe kuyi-FDA. Ukudalula okungabangela ukufa noma ukulimala okungathi sína kuyisenzakalo esingabikwa. Abanikezi kufanele bagcine bonke ubufakazi obuphathekayo, kuhlanganise nomshini ngokwawo, noma isiphi isigqebheko, nanoma isiphi isigxobo, kuze kufike umthetho. Kufanele futhi banciphise ukufinyelela komshini ukuze kuvinjelwe ukungcola kobufakazi.

Abakhi futhi kufanele baqaphele ukuthi ukubambisana nophenyo akulilulazi ilungelo lenkampani lokubekela inselele ukuseshwa okungekho emthethweni. Uma uphenyo olungenamvume lufezwa ngaphandle kwemvume noma ukugunyazwa, umenzi angathatha isinyathelo sokucindezela ubufakazi futhi afune umonakalo wesizwe ngaphansi kuka-42 U.S.C. ngo-1998 ngenxa yokwephulwa kwamalungelo omthetho. Ngakho, abakhiqizi kufanele basebenzise iseluleko somthetho kuqala kunoma ikuphi ukuhlola ukuze baqinisekise ukuthi amalungelo abo avikelwe ngesikhathi esifanayo.

Isiphetho: Ukulinganisela Ukuphepha Komphakathi Namalungelo Omthetho - sisekelo

Izimfuneko eziqinile zemishini yezokwelapha eziphazamisa izimo zibonisa ukulinganisela okubucayi phakathi kwesithakazelo sikahulumeni esishukumisayo sokuvikela iziguli ekungeneleni komkhiqizo okuyingozi nelungelo lomuntu lokukhululeka ekuphazanyisweni okungenangqondo kukahulumeni. Nakuba iSichibiyelo sesine sidinga isiqinisekiso esisekelwa yisizathu okungenzeka, isimo esiphuthumayo sokuguqula izenzakalo ngokuvamile sibangela izimo ezibangela ukusabela okusheshayo, okungenasizathu sokuvimbela ukulimala okwengeziwe. Isimiso sokulawula semishini yezokwelapha sivumela futhi ukuba kuvunyelwe imingcele yokuhlola okungagunyazi ukuphatha, kodwa lokhu kumelwe kuhlale ngaphakathi kwenjongo yokubuyisela futhi kungabi yindawo yokuhlola ubugebengu.

Kumthetho oqashelwayo nababashushisi, impumelelo ixhomeke ekulungiseleleni ngokucophelela: ukudweba izilinganiso ezinemininingwane echaza kokubili ithuluzi kanye nokuguqula, ukwazi ukuthi kufanele kufune nini imvume nokuthi kufanele icele nini, futhi kubhekisele ekufuneni ubufakazi obuqanjiwe. Kubenzi nabaphathi bezempilo, ukuqonda lezimfuneko zomthetho kusiza ukubambisana okungokomthetho futhi kusize ukulondoloza ubufakazi ngaphandle kokudela isivikelo somthetho. Ekugcineni, uphenyo olunenzuzo oluphathelene nokungagcini nje ngokwakha icala eliqinile kodwa lugcina nokwethemba umphakathi ebuqothweni bemishini yezokwelapha nezimiso zobulungisa.

[[Umthetho:0] Imithombo:[[[Umthetho:1]